FDA.reportPublic FDA data

CAREONE

Manufacturer
American Sales Company | Apollo Health and Beauty Care Inc.
Effective date
2017-04-26
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:49:40

Label at a glance#

ProductCAREONE Antibacterial Sanitizer Limoncello
Active ingredientALCOHOL
Label structure6 sections

Indications and uses

to decrease bacteria on the skin.

Dosage and administration

put enough product in your palm to cover hands and rub hands together until dry. children under 6 years should be supervised when using this product.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 65%

Purpose

OTC - PURPOSE SECTION

Antiseptic

Uses

INDICATIONS & USAGE SECTION

to decrease bacteria on the skin.

Warnings

WARNINGS SECTION

For external use only.

  • Flammable
  • Keep away from source of heat or fire

When using this product

OTC - WHEN USING SECTION

avoid contact with eyes. If contact occurs, rinse with water.

Stop use and ask a doctor if

OTC - STOP USE SECTION

irritation or redness develops and lasts.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of accidental ingestion, get medical help or contact a Poison Control Center immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

  • put enough product in your palm to cover hands and rub hands together until dry.
  • children under 6 years should be supervised when using this product.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water (Aqua), Fragrance (Parfum), Carbomer, Glycerin, Isopropyl Alcohol, Isopropyl Myristate, Aminomethyl Propanol, Aloe Barbadensis Leaf Juice, Mannitol, Cellulose, Tocopheryl Acetate, Hydroxypropyl Methylcellulose, Chromium Hydroxide Green (CI 77289), Blue 1 (CI 42090), Yellow 5 (CI 19140).

Label Copy

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of the labelImage of the label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
884783ethanol 65 % Topical SolutionPSN1
884783ethanol 0.65 ML/ML Topical SolutionSCD1
884783ethanol 65 % Topical SolutionSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
41520-411-032020-01-31C16284748780-19d75b9d0-29b9-f424-e053-dadaa90a57ceDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
41520-411-03CAREONEAntibacterial Sanitizer Limoncello59 mL in 1 BOTTLE, PLASTICLIQUID591

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41520-411CAREONE ANTIBACTERIAL SANITIZER LIMONCELLO (ETHYL ALCOHOL) LIQUID [AMERICAN SALES COMPANY]1Legacy NDC, 1 package rows20170427_b53e8d23-22cc-4e3b-81ad-77777821a1ee.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
41520-41141520-411-03

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MACTIB
WATER059QF0KO0RIACT
CARBOMER 934Z135WT9208IACT
GLYCERINPDC6A3C0OXIACT
ISOPROPYL ALCOHOLND2M416302IACT
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
AMINOMETHYLPROPANOLLU49E6626QIACT
ALOE VERA LEAFZY81Z83H0XIACT
MANNITOL3OWL53L36AIACT
POWDERED CELLULOSESMD1X3XO9MIACT
.ALPHA.-TOCOPHEROL ACETATE, DL-WR1WPI7EW8IACT
HYPROMELLOSES3NXW29V3WOIACT
CHROMIUM HYDROXIDE GREENRV8FT8XF5RIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
FD&C YELLOW NO. 5I753WB2F1MIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
37091932-e5e7-4412-b7dc-aef5cde6f03db53e8d23-22cc-4e3b-81ad-77777821a1ee2017-04-26WarningsExact identifier
spl id: 37091932-e5e7-4412-b7dc-aef5cde6f03d
spl set id: b53e8d23-22cc-4e3b-81ad-77777821a1ee

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.